Ear probe for conducting multiple diagnostic hearing tests

ABSTRACT

An ear probe for insertion into a first ear of a patient for conducting multiple diagnostic hearing tests is provided. The probe comprises at least one lumen for transmitting test sounds to the ear of the patient, and at least one lumen for transmitting a hearing test result from the ear of the patient. The hearing test result may be a sound or an electronic signal representing the sound. The lumens are preferably coupled to transducers for providing the test sounds to the patient and transmitting the test result sounds through the ear probe. Multiple test sound lumens and test result lumens may be provided for different hearing tests, and an air delivery lumen is preferably provided for delivering air to and removing air from the ear during tympanometric testing.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application for patent claims the benefit of priority from,and hereby incorporates by reference, U.S. Provisional PatentApplication Serial No. 60/383,303, entitled “Audiometer,” filed on May23, 2002, and U.S. Provisional Patent Application Serial No. ______,entitled “System and Methods for Conducting Multiple Diagnostic HearingTests,” filed on Apr. 29, 2003.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention is directed in general to the field ofaudiological testing for human or animal patients, and more particularlyto systems for conducting multiple diagnostic hearing tests to assessand analyze hearing loss in human patients. Systems of the inventionprovide an apparatus for reliably determining the air-conduction andbone-conduction hearing thresholds of a patient, and for conducting oneor more additional tests involving acoustic immittance, otoacousticemission, speech recognition threshold and speech discrimination. Thesystems further comprise components for performing such tests.

[0004] 2. Description of the Related Art

[0005] Recent studies suggest that over 20 million people in the UnitedStates alone have some degree of hearing loss. The number of peopleworldwide who have some degree of hearing deficit is estimated to bemuch greater. Not surprisingly, many hearing-impaired people are unawarethat they have suffered a decrease in hearing capacity. Because of thecomplexity of the hearing process itself, decreased hearing capacity mayinvolve any of several factors, including age, health, occupation,injury, disease, and exposure to ototoxic agents, including someantibiotics. This loss of hearing can lead to significant reductions inquality of life, impaired relationships, reduced access to employmentand diminished productivity.

[0006] Failure to treat the hearing loss may worsen its impact not onlyon the quality of life of the patient but also on economic productivityas a whole. According to the Better Hearing Institute, the annual costin the United States in terms of lost productivity, special education,and medical care because of untreated hearing loss is approximately $56billion. Much of this staggering cost could be reduced or prevented byearly detection and treatment. Unfortunately, few people obtain regularand frequent hearing tests as a part of their routine healthcare due, atleast in part, to the lack of a simple, convenient, and relativelyinexpensive system for conducting hearing tests.

[0007] Traditionally, hearing tests are conducted in a clinical settingby a hearing health professional, such as an audiologist, whoadministers the hearing tests manually. In perhaps the most common typeof testing, the hearing health professional controls an audiometer toproduce a series of tones that each have a very specific frequency andintensity. The term “intensity” as used herein refers to the amplitudeof the tone and is usually given in decibels (dB), expressed either asSound Pressure Level (dB SPL), which is a logarithmic scale ratio of theintensity of a sound relative to a threshold value, usually 2×10⁻² N/M²,or Hearing Level (db HL), which is a value normalized for a particularfrequency to the threshold for patients with normal hearing. See, e.g.,Gelfand, S., Essentials of Audiology, 2d ed., chapters 1, 3-6, ThiemeMedical Publishers, Inc. (2001).

[0008] Because each of the tones has a specific frequency and intensity,this type of testing is known as “pure-tone” air conduction audiometryor “pure-tone threshold testing” for air conduction. Threshold testingmay also be performed for bone conduction hearing and for speechrecognition. In addition, related tests to determine speechdiscrimination capacity may also be performed. The foregoing types oftesting, which involve providing a sound, such as a pure tone or speech,to the ear of the patient and determining whether the patient can hearor distinguish the sound, are referred to collectively as “audiometry,”or “audiometric testing.” Thus, air-conduction threshold,bone-conduction threshold, speech recognition threshold and speechdiscrimination tests are specific audiometric tests. Other types ofhearing testing include acoustic immittance testing, which includestympanometric testing and acoustic reflex testing, and otoacousticemission testing. Such tests are well known in the art of hearingtesting and are commonly performed by hearing health professionals.

[0009] In the typical manual protocol for pure-tone air-conductionthreshold testing, electrical signals produced by the audiometer areconverted into the desired pure tones by a transducer, such as earphonesor ear inserts, located at or immediately adjacent to the ear of thepatient, who is sequestered in a quiet room or sound isolation booth.For each audible tone, the patient gestures or otherwise indicates thathe has heard the tone. If the tone is not audible, the patient does notrespond. The hearing health professional thereafter adjusts theintensity level of the tone in preset increments until it becomesaudible to the patient. By repeating this process for several differenttones and compiling the results, the hearing health professional is ableto determine the deviation of the patient's hearing threshold, at eachfrequency tested, from the reference hearing threshold established fornormal hearing. The deviation of the threshold, if any, is a measure ofthe patient's hearing loss.

[0010] Manual administration of the pure-tone threshold test has certainadvantages. Because the hearing health professional is physicallypresent, he can apply his considerable training and experience duringthe test. For example, by simply talking to the patient and varying theloudness of his voice, the hearing health professional can determine aninitial intensity level at which to start the tones and sounds.Furthermore, the hearing health professional can adapt the pace of thetest as needed to accommodate a tired or uncooperative patient. Mostimportantly, the hearing health professional can discern between falseresponses or guesses and responses that are legitimate. Finally, thehearing health professional can adjust the results of the hearing testas needed to reflect extenuating circumstances or problems, such asexcessive ambient noise, equipment limitations, and other similarfactors.

[0011] Like most highly trained and specialized medical professionals,however, a hearing health professional's time and services are usuallyvery expensive. Accessibility and convenience can also be issues, asthere are fewer hearing health professionals relative to other types ofmedical professionals. And while hearing health professionals are highlytrained, they are limited in their ability to make rapid and accuratecalculations of the test data and have to rely on approximations andrules of thumb for guidance in many instances. In addition, few hearinghealth professionals in the United States can speak a foreign languageand, therefore, traditional hearing tests are almost always administeredin English, which can be a problem for non-English speaking patients.

[0012] Other drawbacks of the traditional, manually administered hearingtests include the need for a quiet room or sound isolation booth inorder to properly conduct the tests. The quiet room or sound isolationbooth has to comply with ANSI (American National Standards Institute)requirements in terms of how much ambient noise may penetrate the roomor booth during a test. Typically, a specially trained technician mustevaluate and certify the quiet room or sound isolation booth as meetingANSI standards before the room or booth can be used. Such testing and/orcertification is performed independently of the actual testingadministered to a patient, and thus the actual ambient noise levels (andthe reliability of the testing) during the testing of a given patient isunknown in current audiometric systems. In addition, there are atpresent relatively few technicians who are trained to perform suchevaluations and certifications. All the above factors combine toincrease the complexity of the traditional hearing tests and therebydiscourage or at least contribute to a general lack of interest by mostpeople in obtaining regular and frequent hearing tests.

[0013] One attempt to simplify the traditional hearing test involves theuse of a computer network, such as the Internet, to administer the test.The computer network facilitates interaction between a centralized testadministration site and remotely located patient sites. Such anarrangement makes it possible (or at least more convenient) for peoplein remote or rural areas to obtain a hearing test. The test can also beperformed to meet standardized guidelines such as ANSI requirements orcertification standards. Despite the increased convenience, however, ahearing health professional still has to manually administer the test,albeit remotely. In this regard, the test is very similar to thetraditional hearing test and has many of the same shortcomings, inaddition to the fact that the health professional is not physicallypresent.

[0014] Accordingly, there is a need for a simpler, less expensive, andmore convenient system for air-conduction threshold testing (and othertypes of hearing tests) that does not compromise the accuracy orthoroughness of the tests. In particular, there is need for an improvedsystem to provide hearing tests that can be self-administered by thepatient rather than by the hearing health professional, while retainingthe advantages of having a skilled hearing health professional manuallyadminister the test. There is also a need for a system for performinghearing tests that is capable of determining whether ambient noiselevels are within acceptable levels during actual patient testing.

[0015] In addition to the foregoing limitations associated withaudiometric testing, other particular testing limitations precludewidespread hearing testing. One such limitation involves bone-conductionhearing. Because the bones of the skull resonate in response to sound,hearing via bone conduction can be tested in a manner analogous to airconduction. However, instead of pure tones delivered by air conductionthrough earphones or loudspeakers, bone conduction hearing is tested bydelivering sound through a bone-conduction vibrator coupled directly toa bone of the skull, usually the mastoid bone but in some instances theforehead.

[0016] Bone conduction testing is clinically significant becausedifferences between the air-conduction and bone-conduction hearingthresholds provides an indication of how much of a hearing loss isattributable to the conductive structures in the outer and middle ear,and how much is attributable to the sensorineural structures of theinner ear and the auditory nerve. However, a reliable bone-conductiontest apparatus has proven difficult to obtain because of equipmentlimitations. In particular, the vibrator element usually is encased in aprotective plastic shell that is coupled to a holder, typically either aheadset-type spring or a headband. Mastoid-placement bone conduction isparticularly difficult because the anatomy of the mastoid makes slippageand/or shifting of the vibrator common. Physiological differences amongpatients, such as bone contours and fatty deposits in the area, are alsomore variable at the mastoid than the forehead. Even forehead-conductionbone testing may be difficult, however, not only because of insecureplacement and slippage but also because of attenuation of thebone-conduction signal through the holder. Accordingly, there is a needfor an improved bone-conduction test apparatus that provides consistentand secure placement, no attenuation, and reliable results.

[0017] There is a further need for a system capable of conductingmultiple diagnostic hearing tests in a single, convenient system. Whilemany types of diagnostic hearing testing exist, most systems typicallyare capable of performing only a single test or single type of test.Most audiometer systems, for example, are only capable of performingair-conduction and/or bone-conduction threshold testing. Although someaudiometric systems may perform speech recognition testing, there are nocommercially available systems capable of conveniently and reliablyconducting both audiometric testing and acoustic immittance testing. Inaddition, there are no systems available for performing both audiometrictesting and otoacoustic emission testing.

[0018] Inherent in the need for an integrated system for performingmultiple diagnostic tests is the need to conduct such tests in a mannerthat is reliable and convenient for both the hearing health professionaland the patient. Merely combining the functionality of an audiometer andan acoustic immittance testing system will provide little benefit if thesystem is inconvenient to the patient, by for example requiring thepatient to use different headphones or ear probes for each test.Instead, there is a need for a system capable of performing multiplediagnostic tests using a single ear probe and an integrated testingsystem. There is further a need for such systems that are automated toprompt a patient through the tests, while also providing alerts, alarms,notices and other information concerning the tests to a hearing healthprofessional in certain instances.

[0019] A convenient multiple diagnostic testing system also implies thatthe system functionality must be combined in a convenient package thatcan be quickly and easily coupled to the patient, without a clutter ofwires, electrical conduits, transducers and ear probes around thepatient. The risk that patient movement would result in damage to one ormore wires or conduits in the system is another obstacle to combiningmultiple diagnostic tests in a single system. In addition, the presenceof numerous wires, conduits and probes around the patient can beintimidating and distracting to the patient, in addition to beingaesthetically displeasing. Accordingly, there is a need for a systemthat combines multiple diagnostic tests into a patient interface thatcan be quickly and easily coupled to the patient, and which providesminimal clutter in the patient environment.

SUMMARY OF THE INVENTION

[0020] The present invention provides improved systems for conductingmultiple diagnostic hearing tests, and components for performing suchtests. As already noted, there is a need in the art for hearing testsystems capable of performing audiometric testing and other diagnostictests such as acoustic immittance tests and otoacoustic emission tests.In addition, components to provide greater reliability and conveniencein performing such tests are also desirable. Systems according to thepresent invention may be automated to minimize the need for monitoringof the tests by hearing health professionals. The systems also desirablyprovide prompts, alerts or other information to hearing healthprofessionals administering the tests. Reliability of the systems isalso enhanced by providing a modular system with calibration dataprovided as an integral part of certain system components.

[0021] In one embodiment, the invention comprises a system forconducting an audiometric test and at least one of, and preferably bothof, an acoustic immittance test and an otoacoustic emission test in afirst ear of a patient. The system comprises a first insertion probehaving a sealing surface for engaging the external auditory canal of thefirst ear and providing an airtight seal therein. In addition, thesystem preferably comprises a first transducer for providing anaudiometric test sound and at least one of, and preferably both of, anacoustic immittance test sound and an otoacoustic emission test sound tothe first ear through the first insertion probe. In the case ofotoacoustic emission testing, it is preferred that the first transducercomprise a first otoacoustic transducer element and a second otoacoustictransducer element, each of which provides a test sound at a desiredfrequency to generate a distortion product otoacoustic emission in thefirst ear of the patient. The first and second otoacoustic elements mayalso function to deliver other test tones, e.g., pure tone audiometrictones, to the first ear of the patient.

[0022] Where the system is intended to perform tympanometric testing, areversible compressor is provided to deliver and/or remove a gas,preferably air, to and/or from the first ear through the first insertionprobe. The system further comprises a second transducer for receiving atleast one of an otoacoustic emission sound and an acoustic immittancetest result sound from the first ear through the first insertion probe.In a preferred embodiment, the second transducer is an otoacousticemission transducer for receiving an otoacoustic emission sound, and thesystem further comprises a third transducer for receiving an acousticimmittance test result sound selected from the group consisting of atympanogram test result sound and an acoustic reflex test result sound.

[0023] In preferred embodiments of the foregoing system, the firsttransducer comprises at least one speaker for delivering test sounds tothe first ear, and the second and third transducers comprise microphonesfor receiving, respectively, otoacoustic emission sounds and acousticemission test result sounds from the first ear. It will be appreciatedby persons of skill in the art that more than one speaker may beprovided to provide the test sound for each type of hearing test, i.e.,an audiometric speaker, an otoacoustic emission speaker (more preferablyfirst and second otoacoustic emission speakers), and an acousticimmittance speaker may each be separately provided. All such speakerstogether comprise the first transducer, which may also be referred to asa first transducer element for clarity of reference. However, a singlespeaker, or two speakers if the system includes otoacoustic emissiontesting, is preferred to minimize cost and complexity of the system. Itwill also be understood by persons of skill in the art that separatetransducers should preferably be provided for receiving the otoacousticemission sounds and the acoustic immittance test result sounds, becauseof the large differences in intensity of such sounds, although a singletransducer (i.e., microphone) may be used if electronic filtering iscapable of resolving each sound.

[0024] In a further preferred embodiment, the system comprises at leastone, and more preferably two, ambient noise microphones for receivingambient noise from the patient environment during at least a portion ofthe hearing test(s). The invention also preferably comprises a boneconduction vibrator that may be coupled to a first portion of the headof the patient, preferably the forehead, for providing a bone conductionhearing test sound to a skull bone of the patient.

[0025] For simplicity of illustration, the foregoing system has beendescribed for conducting testing for a first ear of a patient. However,it will be understood that in preferred embodiments the system,comprises a second insertion probe, similar to the first insertionprobe, for conducting hearing tests in a second ear of the patient. Itwill also be appreciated that the system preferably comprises a fourthtransducer, preferably one or more speakers, for providing audiometric,tympanometric and/or otoacoustic emission test sounds to the second earthrough the second insertion probe, and fifth and sixth transducers,preferably microphones, for receiving otoacoustic emission test soundsand acoustic immittance test result sounds, respectively, from thesecond ear.

[0026] Systems of the present invention also preferably provide patientmanagement capabilities. More specifically, systems of the inventioncomprise a computer that records and compiles the patient responses andtest results of the diagnostic hearing tests. The computer preferablyanalyzes this data and sends an appropriate message to the hearinghealth professional administering the tests, such as when interventionis needed. For example, when the tests are completed, the patient is notresponding or is responding inappropriately, an email, PDA message or,more preferably, a pager message may be sent to the hearing healthprofessional by the system computer.

[0027] In another aspect, the invention provides an improved insertionprobe for conducting multiple diagnostic tests. As used herein the term“insertion probe” refers to a device for insertion into the externalauditory canal of a patient's ear, and which is used for delivering ahearing test sound to an ear of a patient and for receiving and/ortransmitting a hearing test result from that ear. Insertion probes ofthe present invention are to be distinguished from supra-auralearphones, which are worn over the ear, and circumaural earphones, whichhave foam cushions that fit around the ear, because the insert probesfit within the ear instead of being positioned adjacent to the ear. Inaddition, insert probes of the invention either include a transducer forreceiving a test result sound or transmit a test result sound to such atransducer. Thus, the insert probes may comprise an insert earphone thatis inserted into the ear canal (i.e., the external auditory meatus) butthe earphone must also comprise either a transducer for receiving a testresult sound or a conduit or lumen for transmitting a test result soundto a transducer. As used with respect to the ear probes of theinvention, the terms “lumen” and “conduit” are used interchangeably torefer to open cavities or spaces within the ear probe, which generallyextend from one surface of the probe to another surface thereof.

[0028] Insertion probes of the present invention permit multiplediagnostic hearing tests to be performed with greatly increasedconvenience to the patient and hearing health professional byfacilitating such tests without the necessity of removing the insertionprobe and replacing it with another probe or earphone. In oneembodiment, the insertion probe can be used to conduct an audiometrichearing test and at least one of an acoustic immittance hearing test andan otoacoustic emission test. Thus, the invention provides an insertionprobe capable of being used to conduct an audiometric hearing test andan acoustic immittance hearing test. Alternatively, the inventionprovides an insertion probe capable of being used to conduct anaudiometric hearing test and an otoacoustic emission hearing test.

[0029] In a preferred embodiment, an insertion probe of the presentinvention can be used to conduct an audiometric hearing test, anacoustic immittance hearing test, and an otoacoustic emission hearingtest without changing probes and without removing the insertion probefrom the ear. In a particularly preferred embodiment, the inventionprovides an insertion probe usable to perform an audiometric hearingtest, a tympanogram, an acoustic reflex test, and an otoacousticemission test.

[0030] The multi-test capability of the insertion probes of the presentinvention are facilitated by multiple conduits or lumens within theinsertion probe that either deliver test sounds to the ear or receiveand/or transmit a hearing test result from the ear. At least one conduitis provided for delivering a test sound, such as an air-conduction puretone of a desired frequency and intensity, to the ear. Where otoacousticemission testing is to be performed, two conduits are preferred fordelivering separately to the ear a first otoacoustic emission test soundand a second otoacoustic emission test sound. At least one additionalconduit/lumen is provided to receive and/or transmit a test result to alocation outside the ear. In certain embodiments, the test result isreceived in the conduit as a sound from the ear, such as reflected soundfrom a tympanogram test or acoustic reflex test, and transmitted by aconduit to a transducer element outside the ear for electronictransmission to a computer for further processing. In systems capable ofperforming tympanometric tests, at least one conduit/lumen alsofunctions to allow air or another gas to be delivered to or removed fromthe ear.

[0031] In alternate embodiments, systems of the present inventioncomprise one or more transducer elements within the ear canal itself,medial to the insertion probe. In these embodiments, the transducerreceives sound in the ear that is the direct result or output of thetest, converts the sound to an electronic signal, and the signal istransmitted through the receiving conduit to a processor remote from theear. Accordingly, a receiving conduit in an insertion probe of thepresent invention may transmit sound or electronic signals outside theear.

[0032] Persons of skill in the art will also understand that atransducer may be provided within a conduit, rather than medial orlateral to the insertion probe. In this alternate embodiment, thereceiving conduit may initially receive the test result or output assound energy, which is converted within the conduit to an electricalsignal by the transducer, and transmit the signal through the remainingportion of the receiving conduit to a computer.

[0033] Although a single receiving conduit may be used to transitmultiple test results outside the ear, in preferred embodiments,multiple receiving conduits are preferably provided. It is alsopreferred that the insertion probe be capable of providing an airtightseal within the ear canal by direct contact. An airtight seal isnecessary for conducting a tympanogram test. As used herein, “airtight”refers to a seal having leakage acceptably low for conductingtympanometry testing. It is not required that the seal be completelyairproof, with no leakage, but merely that the leakage be sufficientlysmall to permit tympanometry tests to be conducted on the patient. Byproviding an airtight seal, insertion probes of the present inventioncreate a pressure chamber within the ear canal between the insert probeand the eardrum. A reversible compressor is preferably provided toeither deliver air to the pressure chamber or remove air from thechamber to create the specific pressure conditions necessary forconducting a tympanogram test.

[0034] In a further aspect, the invention comprises systems and methodsfor conducting a hearing test. More particularly, the inventioncomprises systems and methods for delivering a test sound to an ear of apatient in a test area or test room and measuring the ambient noise inthe test area during at least a portion of the hearing test. In contrastto existing hearing test systems, in which the ambient noise levels inthe test area are typically measured only at lengthy intervals such asone year, the present invention allows the ambient noise level to bemeasured and compared to acceptable standards during at least a portionof the actual hearing test for a given patient, i.e., in real time.

[0035] In preferred embodiments, the ambient noise level is measuredsimultaneously with the presentation of each and every test soundprovided to the patient, and for the full duration of the test soundpresentation interval. If the ambient noise level is not withinacceptable levels throughout the test interval, the test sound ispresented to the patient again, and the ambient noise is again measured.This process can continue until the ambient noise level is verified asfalling within acceptable parameters during the presentation of the testsound, or until a preset number of presentations of the test sound arereached. In such instances, the best recorded threshold is logged and anexplanatory note indicating that ambient noise levels exceededacceptable limits is also included in the diagnostic report.

[0036] As used herein, “test area” comprises any area within which thepatient is located while the test is conducted. In preferredembodiments, the test area comprises a relatively quiet room. Asoundproof chamber of the type used in many hearing tests may also beused, although systems and methods of the invention allow accurate andreliable tests to be conducted without use of a soundproof chamber. Thetest area may even comprise an open area or, in extremely demandingconductions, outdoors, although such embodiments are not preferred.

[0037] Accordingly, in one embodiment, the invention comprises a systemfor conducting a hearing test on a first ear of a patient, the systemcomprising a first transducer element for delivering a test sound to thefirst ear, and a second transducer element for measuring ambient noisein the test area. In preferred embodiments, the first transducer elementcomprises a non-field speaker, such as a supraaural, circumaural, orinsert earphone, for delivering the test sound directly to the ear ofthe patient. In particularly preferred embodiments the first transducerelement is coupled to an insertion probe as previously described. Wherefield speakers are used, the sound is typically also detected by thesecond transducer element as ambient noise, which may compromise theeffectiveness of the system. It is also preferred that the secondtransducer element comprise a microphone.

[0038] In a still more preferred embodiment, the system comprises acomputer with software for temporally coupling the speaker and themicrophone to measure ambient noise during the entire pendency of eachand every test tone. In preferred embodiments the computer softwareensures that the test tone is presented to the patient's ear for apredetermined desired time interval, and that the ambient noise in thetest area is measured during at least a portion, preferably the entireduration, of the time interval. Such a testing system essentiallyindependently qualifies (or disqualifies) the test area with each testtone presentation, which provides much greater accuracy and reliabilitythan prior art systems. It will be appreciated, however, that ambientnoise need not be measured during the entire pendency of each and everytest tone, so long as ambient noise is measuring during at least aportion of some test sounds presented to the patient.

[0039] In yet another aspect, the present invention comprises animproved bone conduction hearing test apparatus for testing thebone-conduction hearing threshold of a patient. In one embodiment, theinvention comprises an apparatus for engaging the head of a patient tobe tested for bone conduction hearing, the apparatus comprising a boneconduction vibrator for contacting a first head portion of the patient,an engagement or contact element for contacting a second head portion ofthe patient, and a spring to which the bone conduction vibrator andengagement element are coupled. In a preferred embodiment, the spring isa planar spring comprising first and second elements coupled together.

[0040] In preferred embodiments, the bone conduction vibrator contactsthe forehead of the patient. Although both forehead and mastoidplacement are known in the art, forehead placement is more securegenerally and is made still more secure, reliable and convenient by theapparatus of the present invention. In a still more preferred embodimentof the present invention, the engagement element is coupled to the rearof the patient's head.

[0041] It is preferred that the bone conduction hearing test apparatusprovide two-point contact to the patient's head, by which is meant thatthe apparatus contacts the patient's head at two, and only two, distinctareas, i.e., the first head portion and the second head portion.Although two-point contact bone conduction test elements are known, suchsystems generally comprise a single spring element. Multiple-elementsystems are also known, but such systems must be manipulated in threedimensions (i.e., they are not planar) and they are, more importantly,generally unreliable and difficult to use.

[0042] In another preferred embodiment, the spring comprises opposedfirst and second spring elements, with the bone conduction vibratorcoupled to the first spring element and the engagement element coupledto the second spring element. Such an arrangement facilitates thedesired two-point contact arrangement of the bone conduction hearingtest apparatus. In a particularly preferred embodiment, the first andsecond spring elements are joined at their ends and have opposed middleportions to which the bone conduction vibrator and the engagementelement are coupled. This arrangement provides a lenticular-shapedspring when pulled apart that can easily, conveniently and securely beplaced on the patient's head.

[0043] As referred to herein, “lenticular” refers to a planar, two-sidedlens shape having at least one convex side. Thus, lenticular includesboth the typical bi-convex lens shape characteristic of a lentil inprofile, and also to a mono-convex shape having one convex side and asecond side that is either flat (such as the D-shape of an archery bow)or curved. Where the first and second elements have similar elastic(i.e., spring) characteristics, the shape will by a bi-convex shape.Where the first and second elements have different elasticities, theshape will tend towards a more D-shaped lenticular shape. As may beappreciated, where one element is a rigid element, the spring willcomprise a D-shape. Other shapes, intermediate between a lentil shapeand a D-shape, will be possible where neither element is rigid but wherethe elasticities differ. The; lenticular shape may be convenientlyfacilitated by hinges coupling the respective end portions of the firstand second spring elements. The lenticular-shaped spring is alsoespecially adapted to provide a relatively constant force across a rangeof patient head sizes, the force ranging from about 1 to 15 newtons,more preferably about 2-6 newtons, and most preferably about 5 newtons.

[0044] In another preferred embodiment, the bone conduction hearing testapparatus comprises a spring having first and second contact elementsfor providing two-point contact to the patient's head, said firstcontact element comprising a bone conduction vibrator for contacting thepatient's head at a first area, preferably the forehead. In a still morepreferred embodiment, the spring is a planar, lenticular-shaped spring,and the second contact element comprises an engagement element forengaging the patient's head at a second area, preferably the back of thepatient's head.

[0045] In still another aspect, the system provides a yoke, wearablearound the neck of the patient, for facilitating convenientadministration of multiple diagnostic hearing tests to a patient. Thecomplexity of multiple diagnostic hearing tests requires the presence ofmany conduits, wires, and transducers in the immediate environment ofthe patient. For safety and reliability, it is desirable to provide aconvenient housing for such components. Such a housing is preferablypatient-friendly from a convenience and aesthetic perspective.

[0046] In one embodiment, the invention comprises a system forconducting multiple diagnostic hearing tests in a first ear of apatient, the system comprising a computer for controlling administrationof the multiple diagnostic hearing tests, a plurality of transducers fordelivering signals to and receiving signals from said first ear, atleast one insertion probe for insertion in the first ear, a plurality ofconduits coupling the computer and the plurality of transducers, and ayoke, wearable around the neck of the patient and coupled to the firstinsertion probe, for providing a housing for the plurality of conduits.Such a yoke both protects the conduits from inadvertent damage duringsystem use and also provides a convenient patient interface with thesystem.

[0047] In preferred embodiments, the system comprises a first and secondinsertion probes for insertion into the first and second ears of thepatient. Where two insertion probes are present, the number of conduitsand transducers in the system can be high, and the risk of damage to oneor more conduits increases correspondingly. However, the two probes canbe conveniently coupled to the yoke on either side of the patient'shead, and all of the conduits can be housed within the yoke forprotection.

[0048] In a particularly preferred embodiment, the system comprises atleast one, and more preferably two, ambient noise microphones formonitoring ambient noise during testing and ensuring that it remainswithin acceptable limits. While the ambient noise microphones may beanywhere in the test area, it is preferred that the ambient noisemicrophones be provided near the ears of the patient to more closelyapproximate the noise experienced by the patient. Accordingly, systemsof the present invention preferably comprise a wearable yoke to which atleast one, and preferably two ambient noise microphones are coupled. Theyoke is also conveniently provided with a break therein which may becoupled and decoupled by, for example, Velcro closures for conveniencein use and removal by the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] A better understanding of the invention may be had by referenceto the following detailed description when taken in conjunction with theaccompanying drawings, wherein:

[0050]FIG. 1 illustrates an exemplary system for providing an automatedhearing test according to embodiments of the invention;

[0051]FIG. 2 illustrates a block diagram of the system for providing anautomated hearing test according to embodiments of the invention;

[0052]FIG. 3 illustrates a system for conducting multiple hearing testsaccording to embodiments of the invention, in use by a patient.

[0053]FIG. 4 illustrates a cart and user interface for use in a systemaccording to an embodiment of the invention.

[0054]FIG. 5 illustrates a patient using an embodiment of the invention,and wearing a novel bone conduction testing apparatus.

[0055]FIG. 6 depicts a bone conduction testing apparatus according tocertain aspects of the invention.

[0056]FIG. 7 depicts a wearable yoke according to one aspect of theinvention, and depicting a detachable coupling allowing ease of patientuse.

[0057]FIG. 8 is a block diagram of an ear probe element according to anembodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0058] Following is a detailed description of the invention withreference to the accompanying drawings, in which reference numerals forthe same or similar elements are carried forward.

[0059] In one embodiment, the present invention is directed to a methodand system for automated testing of a patient's hearing. The term“automated” as used herein refers to testing that is performed primarilyby a computer, as opposed to testing that is performed primarily by ahearing health professional. The automated hearing test systempreferably is capable of conducting multiple diagnostic hearing tests,and it allows the patient to test his own hearing with minimal or noassistance from an audiologist or other hearing health professionals.The test provides an accurate and thorough assessment of the patient'shearing, including air and bone conduction testing with masking, speechreception threshold, and speech discrimination tests, as well asacoustic immittance testing and otoacoustic emission testing.

[0060] Such a patient-administered hearing test system is simpler, moreconvenient, and less expensive than the traditionalaudiologist-administered test, while at the same time complying withrelevant standards and guidelines such as ANSI requirements or othercertification standards. In addition, the automated hearing test systemcan detect and compensate for ambient noise and, therefore, does notrequire the use of a certified quiet room or sound isolation booth.Furthermore, the automated hearing test can be configured for any numberof languages in order to accommodate patients in every part of theworld. Using systems according to the present invention, more peoplewill be able to obtain regular and frequent hearing tests.

[0061] Hearing health professionals will also benefit from the automatedhearing test of the present invention. Although the test itself requireslittle or no intervention, a hearing health professional still mustanalyze the test results and recommend treatment. Therefore, theautomated hearing test is presently being made available to the generalpublic through a qualified hearing health professional. The automatedhearing test may be offered as a separate service by the hearing healthprofessional, or as part of a more comprehensive service, such as a fullphysical checkup that patients can obtain annually. Since the testrequires little or no intervention, the hearing health professional hasmore time to treat a larger number of patients and/or spend more timetreating each individual patient. Moreover, since the automated hearingtest facilitates early detection of hearing loss, the hearing healthprofessional may have a relatively easier time treating certainpatients.

[0062] Referring now to FIG. 1, a hearing test system 100 for providingautomated hearing tests according to some embodiments of the inventionis shown. FIG. 1 is a high level diagram and omits details of thesystems of the invention, which are shown in other figures and describedmore fully hereinafter. The hearing test system 100 shown in FIG. 1 hasthree primary components, namely, a computer 102 that comprises thefunctions of one or more hearing test devices, a display screen 104, andan ear engagement element 106. Other components of the system 100 thatmay be present include a keyboard, mouse, printer, paging device, andthe like (indicated generally at 109). The computer 102 may be anysuitable computer from a desktop PC to a high-end workstation, or even aPDA, laptop or tablet PC, as the particular type/model/brand of computeris not overly important to the practice of the invention. The displayscreen 104 may likewise be any suitable display screen from a CRT to aflat-panel LCD, as the particular type/model/brand of display screen isnot overly significant for purposes of the present invention. In someembodiments, however, a touchscreen monitor may be easier for a patientto use than conventional CRT for LCD display screens in terms of thephysical interaction between the patient and the automated hearing testsystem, and is preferred in such instances.

[0063] Ear engagement element 106 is preferably used for air conductionhearing testing as well as acoustic immittance testing and otoacousticemission testing. Although referred to in the singular, ear engagementelement 106 preferably comprises two coupler elements to facilitatemultiple hearing tests in both ears. Ear engagement element 106 maycomprise a speaker coupled to a supraaural, circumaural, insertearphone, an ear probe according to the present invention, or otherearphones complying with applicable government standards such as, e.g.,ANSI S3.6-1996 for delivering the test sound to the ear of the patient.Ear engagement element 106 is preferably coupled to a wearable yoke orvest as depicted generally in FIGS. 3, 5, and 7. Systems of theinvention also preferably comprise a bone conduction hearing test sensorsuch as a bone conduction vibrator. The bone conduction vibrator insystems of the invention is preferably part of a novel bone conductiontest apparatus 150, as depicted in FIGS. 5 and 6 and as described morefully hereinafter. FIG. 2 illustrates the system 100 in block diagramform. Computer 102 has a number of functional components, including avideo unit 200, a central processing unit 202, a hearing test device204, and a storage unit 206. These components are well known in thecomputer art and will therefore be described only briefly here. Ingeneral, the video unit 200 provides the video signals that aredisplayed as images presented to the patient on the display screen 104.In some embodiments, the video unit 200 may be any one of severalcommercially available video cards. The central processing unit 202 isresponsible for the overall operation of the computer 102, includingexecution of the operating system and any software applications residingon the computer 102. In some embodiments, the central processing unit202 may be any one of several commercially available microprocessors.The audio unit 204 provides the audio signals that are converted intothe various tones and speech by the ear engagement element 106. Hearingtest device 204 may comprise any or all of an audiometer, an otoacousticemission test device, a tympanometer, a masking noise generator, orother known hearing test devices. Alternatively, electronic circuitboards performing the functionality of such test devices may also beused. The storage unit 206 provides long-term and temporary (i.e.,caching) storage for the software and data that are used by the computer102 and may include one or more of, for example, a hard drive, mainmemory, removable storage (e.g., CD-ROM, floppy disk), and the like.

[0064] In some embodiments, the storage unit 206 also stores theautomated hearing tests of the present invention, indicated at 208. Morespecifically, the storage unit 206 stores a computer-readable version ofthe automated hearing tests 208, which preferably include audiometrictests, acoustic immittance tests, and otoacoustic emission tests, thatcan be executed by the computer 102, and in particular the hearing testdevice 204. During execution, a portion of the hearing test computerprograms 208 may be temporarily loaded from, for example, the hard diskand into the main memory components of the storage unit 206. In additionto the stand-alone arrangement, it is also possible to execute theautomated hearing test programs 208 from a computer network. Forexample, the automated hearing test programs 208 may be stored on aserver computer (not expressly shown) that is accessible to severalclient computers. This arrangement has an advantage in that updates tothe automated hearing test programs 208 may be quickly and easilyimplemented. Other environments for executing the automated hearing testprograms 208 may also be used without departing from the scope of theinvention.

[0065] The source code for the automated hearing test programs 208 maybe written in any suitable programming language (e.g., C, C++, VisualBasic, and other computer languages). It has been found, however, thatobject oriented programming languages such as C++ and Visual Basic canresult in a somewhat more efficient program. In addition, the automatedhearing test programs 208 can be implemented using a number of differentprogramming methodologies. The particular programming methodology aswell as the particular programming language used are not overlyimportant considerations for the practice of the invention. In oneembodiment, the methodology of the automated hearing test programs 208involves a plurality of individual modules or subroutines that can becalled to perform specific functions. The modules or subroutines can becalled from a main routine and from within other modules or subroutines.The subroutines can pass data to and from each other as well as to andfrom the main routine.

[0066] Systems of the invention are capable of conducting multiplediagnostic hearing tests in a user-friendly manner, while minimizing theneed for extensive supervision and monitoring of the tests by a hearinghealth professional. In particular, systems of the invention are capableof conducting both air-conduction and bone-conduction audiometry hearingtests on a patient (and also preferably speech audiometry includingspeech recognition threshold and speech discrimination tests), plus atleast one additional test that is either an acoustic immittance test oran otoacoustic emission test. The systems are capable of sending adiagnostic message, e.g., an email, PDA message or pager message to ahearing health professional should there by a need for intervening inthe tests, or to signal completion thereof.

[0067] Many types of diagnostic hearing tests are known. As used herein,the terms “audiometry,” “audiometric testing,” and/or “audiometrictests” may be used interchangeably to refer to testing that includesthreshold testing to determine the lowest sound pressure level that apatent may hear either pure tones at specific frequencies, or recognizeand/or distinguish speech. Details of audiometric testing are known inthe art, and certain aspects thereof are described at, e.g., Gelfand,S., Essentials of Audiology, 2d ed., chapters 3, 4, Thieme MedicalPublishers, Inc. (2001).

[0068] The terms “acoustic immittance testing,” and “acoustic immittancetests” are used interchangeably to refer to testing that measures theimpedance to sound flow or, conversely, the ease with which sound flowsthrough the hearing system of the patient. Acoustic immittance testsinclude tympanometric testing, in which the ear canal is pressurized,usually with air, and the immittance of the ear is measured at variouspressures as air is removed from the ear. Such testing is used todetermine whether components of hearing loss are attributable to theouter ear or the middle ear. Acoustic immittance tests also includeacoustic reflex testing, which as used herein refers to testing thatmeasures the immittance changes in the ear that occur reflexively inresponse to a sufficiently intense sound. Details of acoustic immittancetesting are known in the art, and certain aspects thereof are describedat, e.g., Gelfand, S., Essentials of Audiology, 2d ed., chapters 7, 11Thieme Medical Publishers, Inc. (2001).

[0069] Otoacoustic emission testing refers to testing that measuressounds produced by the cochlea of the ear, which are known asotoacoustic emissions (OAEs). Many types of otoacoustic emissions areknown, including spontaneous OAEs, evoked OAEs, and distortion productOAEs. As used herein, the terms “otoacoustic emission tests,” and“otoacoustic emission testing” refer to'testing that measures any of theforegoing types of otoacoustic emissions, particularly distortionproduct otoacoustic emissions, which can provide information on certaintypes of hearing loss. Details of otoacoustic emission testing are knownin the art, and certain aspects thereof are described at, e.g., Gelfand,S., Essentials of Audiology, 2d ed., chapters 7, 11 Thieme MedicalPublishers, Inc. (2001). Other references providing additional detailson audiometric, acoustic immittance, and otoacoustic emission tests arereadily available.

[0070] A system embodying certain preferred aspects of the invention isdepicted in FIGS. 3 and 4. FIG. 3 illustrates a patient 110 using anembodiment of a computer-controlled system 100 for conducting multiplediagnostic hearing tests. FIG. 4 depicts portions of the system 100 thatare interfaced with the patient 110 via cable conduit 120 and displayscreen 104. In general, in these figures a hearing test system 100 isprovided for administering multiple diagnostic hearing tests, includingpreferably audiometric, acoustic immittance, and otoacoustic emissiontests. The system 100 comprises a computer 102, preferably located inthe same housing as the display screen 104, conveniently mounted on asupport arm 118 of a cart 112. The support arm 118 is preferablyadjustable to allow the height of the display screen 104 to becustomized to the height of the patient 110. A plurality of wheels 116is preferably provided on a base 114 of cart 112 to provide mobility tothe system 100. Display screen 104, preferably a touch-sensitive displayscreen as shown, is provided to facilitate testing and patient response.A printer 122 is provided on base 114 to provide printouts of testresults.

[0071] It should also be appreciated that alternative embodimentsdifferent in construction and appearance from the mobile cart systemdepicted in FIGS. 3 and 4 are also within the scope of the invention. Inparticular, systems may comprise stationary systems in a physician'soffice, or laptop and/or mobile systems that may be moved from locationto location to serve a wide patient population.

[0072] As illustrated in FIGS. 3, 5, and 7, the system preferablycomprises a wearable yoke or vest 130 that may be worn around thepatient's neck during the test. The patient may be seated comfortably ina suitable seat (not numbered) adjacent to the touch-screen 104 whilethe multiple diagnostic hearing tests are administered. Yoke 130, andmore particularly the components electrically or otherwise coupledthereto, is coupled to the computer 102 via cable conduit 120.

[0073] As shown in greater detail in FIG. 7, which illustrates anembodiment of a yoke suitable for use in systems of the invention, yoke130 provides a flat, conduit-like housing 132 for the electrical cablesand other conduits, such as an air conduit (not shown) for use intympanometry testing. A plurality of slits or similar openings (notnumbered) are provided in housing 132 of yoke 130 to allow conduits 134for insertion probe elements 140 to extend from the housing 132 to theears of the patient 110. Insertion probe elements 140 generally compriseat least an insertion probe tip 148 and a transducer 138. The transducer138 may be external and separate from probe tip 148, or may beincorporated into it. The insertion probe elements 140 may comprisemultiple transducers, including one or more speaker elements and one ormore receiver elements, e.g., a microphone. The yoke may also be used tohouse additional components of the system to make the system moreindependent of the computer platform. In particular, electronic circuitboards or cards embodying the functionality of an audiometer, anotoacoustic emission test device, a tympanometer, and/or an acousticreflex test device may also be provided and housed within the yoke. Bythis means the systems may be used in connection with a wider range ofcomputer terminal devices. The yoke may also, in preferred embodiments,include a memory element storing calibration data for the transducers(i.e., speakers and microphones) used in the system to allow a computer102 to generate appropriately calibrated signal tones.

[0074] In a preferred embodiment, at least one, and preferably two,ambient noise microphones 142 also extend through slits or openings inyoke 130 to monitor ambient noise during at least a portion of themultiple diagnostic hearing tests. A wire or cable 144 also extendingthrough an opening in yoke 130 couples the yoke to a novel boneconduction apparatus 150.

[0075]FIG. 5 depicts a patient using the novel bone conduction apparatus150 in conjunction with the system of FIGS. 3 and 4. FIG. 6 illustratesthe novel bone conduction apparatus in greater detail. In general, theinvention provides an improved bone conduction test apparatus 150. Theapparatus 150 is generally planar, and provides two-point contact on apatient's head. “Two-point contact” as used herein, means that theapparatus provides contact on two, and only two, particular locations onthe head. Such locations are well-defined and specific, as opposed togeneral contact areas such as along a headband or like means ofcontacting an extensive linear or areal portion of the head of thepatient.

[0076] Returning to FIGS. 5 and 6, the apparatus 150 preferablycomprises a bone vibrator 152, known generally in the art, for engagingthe head at a first location, preferably the forehead. Apparatus 150further comprises an engagement element 154 for engaging the head at asecond location, preferably the back of the head. Engagement element 154may comprise a rigid portion 180, made of hard plastic or like material,and a foam member 178 that directly contacts the second location of thehead. Finally, apparatus 150 comprises and a lenticular spring 156 towhich the bone conduction vibrator 152 and engagement element 154 arecoupled. Apparatus 150 enables two-point contact by using the boneconduction vibrator 152 as a first contact element and the engagementelement 154 as a second contact element.

[0077] Lenticular spring 156 is preferably made by joining opposed firstand second spring elements 158 and 160. Each of the first and secondspring elements further comprises a first end, a middle portion, and asecond end. Thus, first spring element 158 comprises a first end portion162, a middle portion 170, and a second end portion 166. Similarly,second spring element 160 comprises a first end portion 164, a middleportion 172, and a second end portion 168. The first and second springelements 158 and 160 are joined at their first end portions 162 and 164at a first joint or connection 174, and at their second end portions 166and 168 at a second joint or connection 176. The joints/connections 174and 176 may comprise any known means of joining such as riveting,soldering, and other types of metal fastenings. In a particularlypreferred embodiment, joints 174 and 176 both comprise hinge connectionsas depicted in FIG. 6. Bone conduction vibrator 152 and engagementelement 154 are preferably coupled to middle portions 170 and 172,respectively, of first and second spring elements 158 and 160.

[0078] The construction of the bone conduction apparatus 150 as depictedin FIGS. 5 and 6 provides a lenticular-shaped spring 156 that can beeasily pulled apart at the middle portions 170 and 172, and therebyeasily and securely coupled to the patient's head for performing boneconduction hearing testing. Lenticular-shaped spring 156 is alsoespecially adapted to provide a relatively constant force across a rangeof patient head sizes, the force ranging from about 1 to 15 newtons,more preferably about 2-6 newtons, and most preferably about 5 newtons.

[0079] While it is preferred that both the first and second springelements 158, 160 have identical or very similar elasticcharacteristics, in alternate embodiments at least one element,preferably second spring element 160, may be less elastic than the otherspring element. In one alternative embodiment, the second spring elementcomprises a rigid linear member, resulting in a D-shaped lenticularspring (not shown). Other embodiments, in which the second springelement is not rigid, but has is less elastic than the first springelement, are also possible.

[0080] In another embodiment, a thin, flexible member such as a ribbonor cloth (not shown) may be coupled to the second contact element 154and extended over the top of the patient's head to a point on thepatient's forehead. The bone vibrator may then contact the ribbon orcloth, which may comprise a tacky or texturized surface to provide moresecure seating for the bone vibrator. Such a member is particularlyuseful in cases of anatomical irregularities or oily skin. In anotheraspect, the invention provides an improved ear probe element forconducting multiple diagnostic tests. The improved ear probe element ofthe present invention allows multiple diagnostic hearing tests to beconducted without removing the ear probe element from the ear beingtested. This is in contrast to currently available systems, whichgenerally use different ear probe elements to performing, e.g.,audiometric, acoustic immittance, and otoacoustic emission tests.

[0081] The improved ear probe element of the present invention comprisesan insertion probe element. The terms “insertion probe” and “insertionprobe element” refer to a device for insertion into the externalauditory canal of a patient's ear, and which is used for delivering ahearing test sound to an ear of a patient and for receiving and/ortransmitting a hearing test result from that ear. Because they compriseat least a tip portion that fits within the ear instead of beingpositioned adjacent to it, insertion probes of the present invention areto be distinguished from supra-aural and circumaural earphones, whichengage the outer part of the ear (i.e., the pinna). In addition,insertion probes of the present invention either include within theelement a transducer (e.g., a microphone) for receiving a test resultsound, or transmit a test result sound to such a transducer via aconduit within the insertion probe.

[0082] The multi-test capability of the insertion probes of the presentinvention are facilitated by multiple conduits within the probe thateither deliver test sounds to the ear or receive and/or transmit ahearing test result from the ear. FIG. 8 is a block diagram illustratingsuch an insertion probe 300. In particular, the insertion probe elementcomprises an insertion probe tip 301 that is actually inserted into theexternal auditory canal of the patient. The insertion probe comprises aplurality of transducers coupled to insertion probe tip 301, such as aspeaker 302, and first and second microphones 306 and 310.

[0083] In the embodiment illustrated in FIG. 8, the speaker 302 andmicrophones 306 and 310 are shown as separate elements from insertionprobe tip 301, coupled thereto via speaker conduit 304, first microphoneconduit 308, and second microphone conduit 312, respectively. In oneembodiment, first microphone 306 is a microphone for receiving anotoacoustic emission sound from an ear being tested and conduit 308 is aconduit for transmitting the otoacoustic emission sound, while secondmicrophone 310 is an acoustic immittance microphone for receiving atympanometric test result sound and/or an acoustic reflex test resultsound, and conduit 312 is a conduit for transmitting the tympanometricand/or acoustic reflex test result sound. However, in other embodiments(not shown), one or more of the transducers may be provided as a part ofinsertion probe tip 301. In addition, multiple speakers may be providedfor providing different test sounds to a patient, i.e., audiometricthreshold test tones, otoacoustic emission test tones, and tympanometricand/or acoustic reflex test tones.

[0084] The insertion probe element 300 shown in FIG. 8 also provides agas source 314, which is preferably a reversible air compressor, forintroducing and removing air from the ear of the patient. Gas source 14is coupled to insertion probe tip 301 via air conduit 316. Insertionprobe element 300 also comprises a seal 318 to prevent excess airleakage into or from the ear of the patient. The seal provides anairtight seal, which as used herein refers to a seal having leakageacceptably low for conducting tympanometry testing. Thus, it is notrequired that the seal provide a completely airproof seal with noleakage, but merely that the leakage be sufficiently small to permittympanometry tests to be conducted on the patient.

[0085] By providing an airtight seal, insertion probes 300 of thepresent invention create a pressure chamber within the ear canal betweenthe insert probe and the eardrum. A reversible compressor is preferablyprovided to either deliver air to the compression chamber or remove airfrom the chamber to create the specific pressure conditions necessaryfor conducting a tympanogram test.

[0086] It may be appreciated by persons of skill in the art that one ormore of the foregoing conduits 304, 308, 312, 316 may be combined into asingle conduit. Alternatively, individual transducers and gas sourcesmay each have separate conduits passing through the probe tip. Inpreferred embodiments, at least one conduit, such as speaker conduit304, is provided for delivering a test sound, such as an air-conductionpure tone of a desired frequency and intensity, to the ear. Whereotoacoustic emission testing is to be performed, it is preferred thattwo speakers, each having separate conduits, be provided to minimizedistortion of the two sounds used for OAE testing prior to the soundsentering the ear canal.

[0087] At least one additional conduit, such as conduits 308 and 312, isprovided to receive and/or transmit a test result to a location outsidethe ear. Although a single receiving conduit may be used to transitmultiple test results outside the ear, in preferred embodiments,multiple receiving conduits are preferably provided.

[0088] In certain embodiments of the insertion probe 300, the testresult is received in the conduit as a sound from the ear, such asreflected sound in a tympanogram test or acoustic reflex test, and thesound is transmitted by a conduit to a transducer element outside theear for electronic transmission to a computer for further processing.

[0089] In alternate embodiments (not shown), insertion probe 300comprises one or more transducer elements within the ear canal itself,medial to the probe tip 301. In these embodiments, the transducer (e.g.,microphones 306, 310) receives sound in the ear that is the directresult or output of the test, converts the sound to an electronicsignal, and the signal is transmitted through the probe tip 301 andreceiving conduit (e.g., 308, 312) to a processor remote from the ear.Accordingly, a receiving conduit in an insertion probe of the presentinvention may transmit either sound or electronic signals through theprobe tip 301 outside the ear.

[0090] Persons of skill in the art will also understand that atransducer may be provided within the probe tip 301, rather than medialor lateral to it. In this alternate embodiment (not shown), thereceiving conduit may initially receive the test result or output assound energy, which is converted within the conduit (and within probetip 301) to an electrical signal by the transducer, and the signal isthen transmitted as an electrical signal through the remaining portionof the receiving conduit to a computer.

[0091] As noted, insertion probes 300 of the present invention permitmultiple diagnostic hearing tests to be performed without removing theinsertion probe and replacing it with another probe or earphone. In oneembodiment, the insertion probe 300 can be used to conduct anaudiometric hearing test and at least one of an acoustic immittancehearing test and an otoacoustic emission test. Thus, the inventionprovides an insertion probe 300 capable of being used to conduct anaudiometric hearing test and an acoustic immittance hearing test.Alternatively, the invention provides an insertion probe capable ofbeing used to conduct an audiometric hearing test and an otoacousticemission hearing test.

[0092] In a preferred embodiment, an insertion probe of the presentinvention can be used to conduct an audiometric hearing test, anacoustic immittance hearing test, and an otoacoustic emission hearingtest without changing probes and without removing the insertion probefrom the ear. In a particularly preferred embodiment, the inventionprovides an insertion probe usable to perform an audiometric hearingtest, a tympanogram, an acoustic reflex test, and an otoacousticemission test.

[0093] In a further aspect, the invention comprises systems and methodsfor conducting a hearing test. More particularly, the inventioncomprises systems and methods for delivering a test sound to an ear of apatient and measuring the ambient noise in the test area during at leasta portion of one or more of the multiple diagnostic hearing tests. Incontrast to existing hearing test systems, in which the ambient noiselevels in the test area are typically measured and only certifiedperiodically, and then not during hearing testing, the present inventionallows the ambient noise level to be measured and compared to acceptablestandards during at least a portion of the actual hearing test for agiven patient.

[0094] In preferred embodiments, the ambient noise level is measuredsimultaneously with the presentation of every test sound presented tothe patient. If the ambient noise level is unacceptably high during thepresentation of the test sound, the test sound is presented to thepatient again, and the ambient noise is again measured. This processcontinues until the ambient noise level is within acceptable parametersduring the presentation of the test sound, or until a preset number ofpresentations of the test sound are reached. In the latter instance, thebest recorded threshold is logged and an explanatory note is included inthe test results report indicated that ambient noise exceeded acceptablelevels.

[0095] As illustrated in FIGS. 3, 5 and 7, in one embodiment, theinvention comprises a system for conducting a hearing test on a firstear of a patient, the system comprising a first transducer element 138for delivering a test sound to the first ear, and at least a secondtransducer element 142 for measuring ambient noise in the test area. Inpreferred embodiments, the sound is delivered to the ear by an insertprobe element 140 or other non-field speaker. Where field speakers areused, the sound is typically also detected by the second transducerelement as ambient noise, which may compromise the effectiveness of thesystem. It is also preferred that the second transducer element 142comprise a microphone.

[0096] In a still more preferred embodiment, the system comprises acomputer with software in computer 102 for coupling the transducer 138and the microphone 142 to simultaneously measure ambient noise viamicrophone 142 during the entire period of presentation of the test toneto the ear. In preferred embodiments the computer software ensures thatthe test tone is presented to the patient's ear for a predetermineddesired time interval through transducer 138 and insertion probe element140, and that the ambient noise in the test area is measured during atleast a portion, preferably the entire duration, of the time intervalthrough microphone 142. Such a testing system essentially independentlyqualifies (or disqualifies) the test area with each test tonepresentation, which provides much greater accuracy and reliability thanprior art systems. It will be appreciated, however, that ambient noiseneed not be measured during the entire pendency of each and every testtone, so long as ambient noise is measured during at least a portion ofsome test sounds presented to the patient. In an alternate embodiment,the ambient noise measurement may be made during a portion of the testthat is not part of the presentation of the test sounds, such asimmediately before or after the test sounds are presented. Indeed, evenmeasuring the ambient noise immediately prior to conducting the hearingtests on the patient is permissible and represents and significantimprovement over prior art practices, which do not involve ambient noisemeasurement proximate in time to actual hearing testing of patients.

[0097] It will be appreciated that many alterations, modifications andchanges may be made by persons of skill in the art to the systems andcomponents described herein. Such changes are deemed to be within thescope and spirit of the invention, as measured by the claimshereinafter.

What is claimed is:
 1. An insertion probe for conducting multiple diagnostic hearing tests in a first ear of a patient, said multiple tests comprising an audiometric hearing test and a second hearing test selected from the group consisting of an acoustic immittance hearing test and an otoacoustic emission hearing test.
 2. The insertion probe of claim 1, wherein said second hearing test is an acoustic immittance hearing test selected from the group consisting of a tympanogram test and an acoustic reflex test.
 3. The insertion probe of claim 1, wherein said second hearing test is an otoacoustic emission test.
 4. The insertion probe of claim 1 further comprising at least one sound lumen for delivering an audiometric test sound, an acoustic immittance test sound, and an otoacoustic emission test sound to said first ear, and at least one receiver lumen for transmitting a hearing test result selected from the group consisting of an acoustic immittance test result sound, an electronic signal representing an acoustic immittance test result, an otoacoustic emission sound, and an electronic signal representing an otoacoustic emission sound.
 5. The insertion probe of claim 4 wherein said at least one sound lumen comprises a plurality of lumens for delivering said audiometric test sound, said acoustic immittance test sound, and said otoacoustic emission test sound to said first ear.
 6. The insertion probe of claim 4 wherein said at least one receiver lumen comprises a plurality of receiver lumens.
 7. The insertion probe of claim 6 wherein said plurality of receiver lumens comprises at least an acoustic immittance receiver lumen for transmitting an acoustic immittance hearing test result selected from the group consisting of an acoustic immittance test result sound and an electronic signal representing an acoustic immittance test result, and an otoacoustic emission receiver lumen for transmitting an otoacoustic emission hearing test result selected from the group consisting of an otoacoustic emission sound and an electronic signal representing an otoacoustic emission sound.
 8. A system for conducting an audiometric hearing test and an otoacoustic emission hearing test in a first ear of a patient comprising a first probe element for insertion into the external auditory canal of said first ear, said system being capable of conducting both an audiometric test and an otoacoustic emission test in said first ear after insertion of said first probe element.
 9. The system of claim 8 wherein said first probe element comprises at least one sound conduit for delivering an audiometric test sound and an otoacoustic emission test sound to said first ear, and at least one receiver conduit for transmitting an otoacoustic emission test result selected from the group consisting of an otoacoustic emission sound, and an electronic signal representing an otoacoustic emission sound.
 10. The system of claim 9 further comprising at least one speaker for providing an audiometric test sound and an otoacoustic emission test sound to said first ear through said at least one sound conduit, and at least one microphone for receiving an otoacoustic emission sound from said first ear.
 11. The system of claim 10 wherein said at least one speaker is positioned adjacent to said first probe element.
 12. The system of claim 10 wherein said at least one microphone is positioned within said first probe element.
 13. The system of claim 8 further comprising a second probe element for insertion into the external auditory canal of a second ear of said patient, wherein said system is capable, after insertion of said first and second probe elements, of conducting both an audiometric test and an otoacoustic emission test in both said first ear and said second ear without removing said first and second probe elements from said first and second ears.
 14. The system of claim 8 wherein said first probe element further comprises a sealing element for providing an airtight seal within the external auditory canal.
 15. The system of claim 14 wherein said seal comprises an elastomeric polymer foam and provides said airtight seal by engagement between said foam and said external auditory canal.
 16. The system of claim 14 wherein said first probe element provides said airtight seal to create a pressure chamber within said external auditory canal, said pressure chamber comprising a portion of the external auditory canal bounded on the lateral side by the first probe element and on the medial side by the patient's eardrum.
 17. The system of claim 16 further comprising an air compressor for providing an air pressure to the pressure chamber.
 18. The system of claim 17 wherein the air compressor is reversible and is capable of delivering air to and removing air from the pressure chamber.
 19. The system of claim 18 wherein the air compressor is capable of creating a positive pressure or a negative pressure in the pressure chamber.
 20. A system for conducting an audiometric hearing test and an acoustic immittance hearing test in a first ear of a patient comprising a first probe element for insertion into the external auditory canal of said first ear, said system being capable of conducting both an audiometric test and an acoustic immittance test in said first ear after insertion of said first probe element.
 21. The system of claim 20 wherein said first probe element comprises at least one sound conduit for delivering an audiometric test sound and an acoustic immittance test sound selected from the group consisting of a tympanogram test sound and an acoustic reflex test sound to said first ear, and at least one receiver conduit for transmitting an acoustic immittance hearing test result selected from the group consisting of an acoustic immittance test result sound and an electronic signal representing an acoustic immittance test result.
 22. A system for conducting an audiometric hearing test and an otoacoustic emission hearing test in a first ear of a patient comprising a first probe element for insertion into the external auditory canal of said first ear, said system being capable of conducting both an audiometric test and an otoacoustic emission test in said first ear without removing said first probe element from said first ear.
 23. The system of claim 22, further comprising a second probe element for insertion into the external auditory canal of a second ear of said patient, wherein said system is capable, after insertion of said first and second probe elements, of conducting both an audiometric test and an otoacoustic emission test in both said first ear and said second ear without removing said first and second probe elements from said first and second ears.
 24. A system for conducting an audiometric hearing test and an acoustic immittance hearing test in a first ear of a patient comprising a first probe element for insertion into the external auditory canal of said first ear, said system being capable of conducting both an audiometric test and an acoustic immittance test in said first ear without removing said first probe element from said first ear.
 25. A system for conducting multiple diagnostic hearing tests in a first ear of a patient comprising a first probe element for insertion within said first ear, said system being capable of conducting each of an audiometric threshold hearing test, a tympanogram test, an acoustic reflex test, and an otoacoustic emission test in said first ear without removing said first probe element from said first ear.
 26. The insertion probe of claim 25 further comprising at least one sound conduit for delivering an audiometric test sound, a tympanogram test sound, an acoustic reflex test sound, and an otoacoustic emission test sound to said first ear.
 27. The insertion probe of claim 26 further comprising a first receiver conduit for transmitting a hearing test result selected from the group consisting of an otoacoustic emission sound and an electronic signal representing an otoacoustic emission sound, and at least a second receiver conduit for transmitting a hearing test result selected from the group consisting of an a tympanogram test result sound, an electronic signal representing a tympanogram test result sound, an acoustic reflex test result sound, and an electronic signal representing an acoustic reflex test result sound.
 28. An insertion probe for conducting multiple diagnostic hearing tests in a first ear of a patient, each of said multiple diagnostic hearing tests being conducted by providing a sound through said insertion probe to said first ear, receiving a sound from said first ear through said probe, or both providing a sound through said insertion probe and receiving a sound through said insertion probe. 